EP1151345B1 - Verfahren zur herstellung einer kontaktlinse - Google Patents

Verfahren zur herstellung einer kontaktlinse Download PDF

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Publication number
EP1151345B1
EP1151345B1 EP00902778A EP00902778A EP1151345B1 EP 1151345 B1 EP1151345 B1 EP 1151345B1 EP 00902778 A EP00902778 A EP 00902778A EP 00902778 A EP00902778 A EP 00902778A EP 1151345 B1 EP1151345 B1 EP 1151345B1
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EP
European Patent Office
Prior art keywords
lens
shape
front surface
eye
back surface
Prior art date
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Expired - Lifetime
Application number
EP00902778A
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English (en)
French (fr)
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EP1151345A1 (de
Inventor
John Haldyn Clamp
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Contact Lens Precision Laboratories Ltd
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Contact Lens Precision Laboratories Ltd
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Application filed by Contact Lens Precision Laboratories Ltd filed Critical Contact Lens Precision Laboratories Ltd
Publication of EP1151345A1 publication Critical patent/EP1151345A1/de
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    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00—Optical parts
    • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04—Contact lenses for the eyes

Definitions

  • This invention relates to a contact lens and to a method of making a contact lens.
  • Contact lenses are generally designed to correct visual problems associated with focal power of the eye, and currently this is normally achieved by controlling the focal power of a contact lens using a selected combination of front and back surface curvatures, lens thickness and selection of lens material refractive index. In this way there is imparted to the contact lens a power appropriate to achieve some degree of correction for the optical defects of the eye of the wearer. Generally, however, the focal power cannot be fully controlled at all optical areas of the lens, resulting in the required focal power being only achieved at the central region of the useful optic area of the lens.
  • One application of the present invention is to control aberrations in the lens itself and of the lens eye system when the lens is in situ on the eye.
  • contact lenses eg "aberration control" lenses, having a front aspheric surface curvature, are available eg from Lamda Polytech Limited and from Nissel Limited. However, these lenses are available only in very limited parameters (eg a soft lens of 38 % Hema) and importantly are available only with a back surface curvature specified by the manufacturer.
  • a method of making a contact lens comprising the steps of: calculating the shape of an aspheric curve to be imparted to the front surface of the lens in order to provide a desired focal power profile over the optic region of a monofocal or multifocal contact lens, by:-
  • step (b) includes simulating the passage of light through the lens eye system, including the refractive surfaces within the lens eye system such as the tear layer, cornea, aqueous humour, crystalline lens and vitreous humour.
  • the refractive surfaces may include a change in the optical properties of the lens eye system by such as the inclusion of optical medical devices implanted into or onto the eye.
  • Step (c) may include representing the desired power map as a mathematical equation or series of equations.
  • the mathematical equation or series of equations are a polynomial equation or series of polynomial equations.
  • step (d) comprises:
  • the method may include defining the accuracy of the machining equipment and manufacturing process used to manufacture the lens and, at incremental values, relating the mathematical equation previously derived to the actual point and investigating whether the points are within the previously defined accuracy of the machining equipment and manufacturing process.
  • the method may use a mathematical equation such as a polynomial curve of sufficient order or higher, until the profile or all of the points are defined to the required accuracy.
  • the method includes calculating a shape change function from the difference between the back
  • the method includes calculating a shape change function from the difference between the back surface shape of the lens and the resultant shape of the back surface of the lens once in situ on the eye, and incorporating the change in conic eccentricity of the back surface of the contact lens where applicable, and applying the shape change function to the derived mathematical equation defining the front geometry of the lens.
  • the present invention in its preferred form, is a great improvement as it provides a method of manufacturing a contact lens which has fully controlled power distribution at all optical parts of the lens, both in air and as part of the lens eye system when in situ on eye, and definable with any lens material and specification including any desired back surface curvature (eg spherical, aspherical or polynomial) as specified by the manufacturer or by a practitioner fitting the lens. Additionally the present invention enables the optimisation of the lens manufacturing process for producing the appropriate front surface of the lens by accounting for the accuracy of the manufacturing process and equipment. The present invention is applicable to all lens types including monofocal, multifocal, prismatic, toric lenses and combinations thereof.
  • the present invention in its preferred form, takes into consideration the effect of shape changes in the lens due to the draping of the lens when in situ on the eye and shape changes to the lens material during manufacture.
  • the contact lens contains a toric portion, whether on the back, front or both surfaces, the above process is repeated across each axis of the toric portion.
  • step (b) is accommodated to include the offset surfaces.
  • the profile of the front surface curvature for the contact lens can be determined.
  • the lens can then be manufactured using conventional modern contact lens manufacturing techniques such as computer numerical control (CNC) lathe cutting and cast moulding.
  • CNC computer numerical control
  • the contact lens according to the invention has a single, substantially uniform focal power across substantially the entire optic area of the lens, or each incremental part thereof.
  • a lens may be considered to have a "substantially uniform" focal power across its optic area, or each incremental part thereof, if, for a typical lens, the focal power deviates by less than 1 dioptre, preferably less than 0.5 dioptres, and more preferably by less than 0.25 dioptres.
  • the optic area of the lens may be defined as that part of the surface of the lens falling within a circle, which circle is centred on the centre of the lens and which has a diameter equal to the front optic zone diameter (FOZD) of the lens.
  • the FOZD of a lens is defined in ISO 8320-1986.
  • the FOZD is the diameter of that portion of the front surface of the lens which is intended to provide the desired optical correction to the wearer of the lens.
  • a contact lens may be made so as to have a FOZD of any desired size.
  • the FOZD will normally be determined primarily by the total diameter of the lens.
  • a typical rigid gas permeable (RGP) lens of single power may have a total diameter of 9.5mm, and the FOZD of such a lens will typically be in the range 6-8.5mm.
  • substantially the entire optic area of the lens in accordance with the invention may be around 65 % of the optic area for a lens with a large FOZD, but will preferably be at least 75 %, more preferably at least 80% and most preferably at least 90 % of the optic area for more normal lenses in accordance with the invention.
  • the curvature of the back surface remains determinable by the manufacturer or the optician fitting the lens.
  • the back surface may be selected to be either spherical or aspheric for the purpose of aiding fitting to the eye.
  • the invention is applicable to all types of contact lens (rigid or soft), regardless of replacement frequencies, such as
  • the invention may offer the following benefits to the wearer of contact lenses:
  • the wearer will be attaining the prescribed power correction; generally, contact lenses give an average power correction which is dependent on the prescribed power and lens-induced spherical aberration effects.
  • the pupil of the wearer expands. This allows more light through peripheral areas of the contact lens where, in conventional contact lenses, the focal power deviates from the prescribed power. This may also cause halo/flare effects. This effect is significantly reduced when the prescribed power is constant over substantially the complete optic area, as in lenses in accordance with the present invention.
  • Lens movement helps induce tear flow underneath the contact lens which leads to healthier conditions, by increasing oxygen availability for the eye.
  • lens movement especially lens movement caused by blinking
  • Increased lens movement is permissible for lenses that have the prescribed power across the complete optic area, as the wearer will not perceive any loss of visual acuity.
  • the first step of the method comprises;
  • the second step of the method comprises incrementing Y from 0.00 to FOZD/2 in incremental steps.
  • angles at which the light ray refracts from each external and internal surface are required. These angles relate to the angle between the incident light ray and the perpendicular of the surface at that point.
  • back vertex power (BVP)
  • Step (d) comprises:
  • the front eccentricity value and front radius of the lens or each incremental part is adapted in an iterative process, then the process is repeated until the profile of the power map corresponds to the desired profile.
  • the previous equations may be extended to incorporate the additional refracting surfaces of the eye, which include the tear lens, cornea, aqueous humour, crystalline lens and vitreous humour. This will allow for the control of power at each part of the contact lens in the complete lens eye system.
  • the shape of the tear lens is determined by the back surface of the contact lens and the front of the cornea (which is typically measured by the practitioner, using keratometry). For a flexible lens, any drape of the lens is taken into account.
  • the thickness of the tear layer is estimated from the geometrical point of contact between the lens and the cornea (typically in the range 5-10 ⁇ m). For the purposes of the determining the geometry of the other refractive surfaces within the eye, a modified schematic of the Gullstrand number 1/2 model or the Le Grand model may be used.
  • D previous angle of refraction
  • F angle of incidence
  • Ri n refractive index of the incident medium
  • Ri n+1 refractive index of the refracting medium
  • back vertex power (BVP) is then consistent with the equations detailed previously.
  • An iterative process is used to adjust the position of X n until the resulting value for BVP is equal to the desired power profile at incremental distance y from the central optical axis of the contact lens.
  • the value for x n is stored against value y n in a memory device.
  • An iterative process is used to determine the order of the polynomial equation necessary to describe the nodal points x 0 to x n against the incremented values of y 0 to y n to the accuracy required by the manufacturing process.
  • the polynomial equation must describe the position of the nodal points to an accuracy of ⁇ 2 ⁇ m, more preferably to an accuracy of ⁇ 1 ⁇ m and most preferably to an accuracy of ⁇ 0.5 ⁇ m.
  • the shape imparted to the front surface of a flexible lens is compensated for the action of the contact lens draping on the surface of the eye.
  • the shape change factors t y and t x are applied directly to the polynomial equation describing the front surface of the flexible contact lens.
  • the determination of the shape change factors t x and t y in this instance correspond respectively to the axial and the radial expansion factors of the material.
  • contact lenses having aspheric front surfaces in accordance with the invention are given below.
  • the contact lenses manufactured in accordance with the invention, having substantially uniform focal power across substantially the entire optic area, are aplanatic lenses corrected for induced spherical aberration, and are now referred to as such. These aplanatic lenses are compared with non-aplanatic contact lenses computed conventionally and having spherical front surfaces.
  • lens pairs A and B each having aplanatic lens 1 and non-aplanatic, standard lens 2 are compared:- Lens Pair A Lens Pair B Lens 1 Lens 2 Lens 1 Lens 2 BOZR 8.00 8.00 8.00 8.00 TD 9.50 9.50 9.50 9.50 FOZD 8.00 8.00 8.00 8.00 FOZR 7.21 7.21 9.21 BVP + 8.00 + 8.00 - 8.00 - 8.00 Tc 0.35 0.32 0.14 0.14 Fel 0.471 0.00 - 0.627 0.00 Aplanatic Yes No Yes No Yes No Yes No Yes No Yes No Yes No
  • the lenses were manufactured using standard materials (PMMA - polymethyl methacrylate) and standard contact lens lathe cutting equipment and measured using a Visionix VC2001 lens mapping system,
  • Figure 7 shows the theoretical or predicted power distributions over the useful, optic areas of the lenses of pair A (at the top) and pair B (below).
  • the graphs plot focal power (DS) against distance from the lens centre in mm and it can readily be seen that, for each pair, lens 1, the aplanatic lens, theoretically has a uniform power distribution over the useful optic area, whilst in each case lens 2, the non-aplanatic lens, shows a focal power increasing or decreasing from the power at the centre of the lens.
  • Figures 8A to 8D are power distribution maps for contact lenses 1 and 2 of pairs A and B, obtained subsequent to manufacture. Each map is associated with a key in the form of focal power scale.
  • the inner circle in each map defines the useful, optic area of the lens, and it can readily be seen that, for each pair, within these areas, lens 1 of the pair has substantially uniform focal power relative to lens 2.
  • the invention as described enables contact lenses to be manufactured with substantially constant focal power across a desired diameter; applies to all designs of contact lenses, whichever manufacturing process is used, without altering the fitting characteristics of the lens; offers significant clinical and commercial advantages; and enables contact lenses to be manufactured using standard equipment, of all modalities and techniques, and therefore does not increase running costs of manufacture.

Claims (8)

  1. Ein Verfahren zur Herstellung einer Kontaktlinse, das folgende Schritte umfasst: die Form einer aspärischen Kurve zu berechnen, die auf die vordere Oberfläche der Linse übertragen werden soll, um ein gewünschtes Brechkraft-Profil über den optischen Bereich einer monofokalen oder multifokalen Kontaktlinse zu erreichen, indem:
    (a) die erforderliche Form der vorderen Oberfläche der Linse geschätzt wird, um eine geschätzte Form durch die Verwendung von Standardformeln oder adaptierten Formeln für dünne Linsen zu erreichen;
    (b) die Brechkraft der Linse mit der geschätzten Form berechnet wird durch Simulieren des Durchgangs von parallel oder ausnahmsweise nicht parallel einfallenden Lichtstrahlen durch die Linse hindurch an Punkten mit wachsenden Abständen von der optischen Achse der Linse, um ein Brechkraft-Abbild der Linse zu erstellen;
    (c) das Profil des Brechkraft-Abbildes für die Linse bestimmt wird;
    (d) ein iterativer Prozess eingesetzt wird, um die erforderliche Form der vorderen Oberfläche zu schätzen, und zwar durch Wiederholen der Schritte (b) und (c), bis das Profil des Brechkraft-Abbildes dem gewünschten Profil und einer gewünschten Genauigkeit entspricht,
    dadurch gekennzeichnet, dass die Kontaktlinse aus einem Material hergestellt ist, das nicht-isotrope Formänderungs-Eigenschaften aufweist, wie etwa Ausdehnung oder Schrumpfung, und wobei die erforderliche Formänderungs-Funktion aus den nicht-isotropen Materialeigenschaften der Linse berechnet wird, und wobei die Veränderung der konischen Exzentrizität der Linsenflächen, wo zutreffend, eingearbeitet wird, und wobei die Formänderungs-Funktion auf das in Schritt (d) abgeleitete Profil angewendet wird.
  2. Ein Verfahren nach Anspruch 1, dadurch gekennzeichnet, dass Schritt (b) das Simulieren des Durchgangs von Licht durch das Augenlinsensystem umfasst, einschließlich der refraktiven Oberflächen innerhalb des Augenlinsensystems, wie beispielsweise Tränenschicht, Hornhaut, Kammerwasser, kristalline Linse und Glaskörperflüssigkeit.
  3. Ein Verfahren nach Anspruch 2, dadurch gekennzeichnet, dass die optischen Eigenschaften der refraktiven Oberflächen infolge der Einbeziehung von optischmedizinischen Mitteln geändert werden, die in oder auf das Auge implantiert werden.
  4. Ein Verfahren nach Anspruch 1, dadurch gekennzeichnet, dass Schritt (c) die Darstellung des gewünschten Brechkraft-Abbildes als mathematische Gleichung oder als Reihe von mathematischen Gleichungen umfasst.
  5. Ein Verfahren nach Anspruch 4, dadurch gekennzeichnet, dass die mathematische Gleichung eine Polynom-Gleichung ist oder die Reihe von mathematischen Gleichungen eine Reihe von Polynom-Gleichungen ist.
  6. Ein Verfahren nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass der Schritt 1(d) umfasst:
    (e) einen Punkt auf der Vorderfläche der Linse als Anfangspunkt zu definieren;
    (f) den Durchgang von parallel oder ausnahmsweise nicht parallel einfallenden Lichtstrahlen durch die Linse zu simulieren und dabei die Geometrie der rückwärtigen Oberfläche der Linse zu berücksichtigen, in wachsendem Abstand, wobei der Punkt auf der Vorderfläche der Linse entweder näher zu oder entfernter von der rückwärtigen Oberfläche der Linse in einer solchen Stellung eingestellt wird, dass die gebrochenen Lichtstrahlen durch die optische Achse an der Stelle hindurchgehen, die von dem gewählten definierten Brechkraft-Abbild angezeigt wird;
    (g) einen neuen Punkt auf der Vorderfläche der Linse in einem größeren Abstand zu dem vorigen Punkt zu definieren;
    (h) die Schritte (f) und (g) zu wiederholen, bis alle gewählten Punkt so berechnet sind, dass sie die gewünschte Linsenfläche abdecken; und
    (i) ein mathematisches Anpassverfahren zu verwenden, wie etwa ein Polynomkurven-Anpassverfahren, um eine mathematische Gleichung an die definierten Punkte anzupassen.
  7. Ein Verfahren nach Anspruch 5 und 6, ebenso umfassend die Bestimmung der Genauigkeit der Bearbeitungsgeräte und des Herstellungsverfahrens, das für die Herstellung der Linse eingesetzt wird, sowie, mit ansteigenden Werten, die Anwendung der in Anspruch 5 oder 6(i) abgeleiteten mathematischen Gleichung auf den betreffenden Punkt und die Prüfung, ob die Punkte innerhalb der zuvor bestimmten Genauigkeit der Bearbeitungsgeräte und des Herstellungsverfahrens liegen, sowie die Erhöhung der Polynom-Ordnung der mathematischen Gleichung, bis die Punkte innerhalb dieser Genauigkeit liegen.
  8. Ein Verfahren nach jedem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Kontaktlinse als biegsam betrachtet wird, wie etwa eine weiche Hydrogel- oder Silikonlinse, und dass eine Formänderungs-Funktion berechnet wird aus der Differenz zwischen der Form der rückwärtigen Fläche der Linse und der sich ergebenden Form der rückwärtigen Fläche der Linse, wenn sie in situ auf dem Auge sitzt, und dass die Änderung der konischen Exzentrizität der rückwärtigen Fläche der Kontaktlinse, wo anwendbar, einbezogen wird, und dass die Formänderungs-Funktion auf die abgeleitete mathematische Gleichung angewandt wird, die die Vorderflächen-Geometrie definiert.
EP00902778A 1999-02-13 2000-02-11 Verfahren zur herstellung einer kontaktlinse Expired - Lifetime EP1151345B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9903170 1999-02-13
GBGB9903170.0A GB9903170D0 (en) 1999-02-13 1999-02-13 Contact lenses
PCT/GB2000/000445 WO2000048036A1 (en) 1999-02-13 2000-02-11 Contact lenses and methods of manufacture

Publications (2)

Publication Number Publication Date
EP1151345A1 EP1151345A1 (de) 2001-11-07
EP1151345B1 true EP1151345B1 (de) 2006-04-26

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EP00902778A Expired - Lifetime EP1151345B1 (de) 1999-02-13 2000-02-11 Verfahren zur herstellung einer kontaktlinse

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EP (1) EP1151345B1 (de)
JP (1) JP2002536701A (de)
AT (1) ATE324611T1 (de)
AU (1) AU2451800A (de)
DE (1) DE60027545T2 (de)
GB (2) GB9903170D0 (de)
WO (1) WO2000048036A1 (de)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6467903B1 (en) 2000-03-31 2002-10-22 Ocular Sciences, Inc. Contact lens having a uniform horizontal thickness profile
US6595640B1 (en) * 2000-11-15 2003-07-22 Johnson & Johnson Vision Care, Inc. Method for designing contact lenses
US7111938B2 (en) 2001-04-27 2006-09-26 Novartis Ag Automatic lens design and manufacturing system
US7384143B2 (en) 2002-07-24 2008-06-10 Novartis Ag Method of manufacturing a contact lens
JP4485360B2 (ja) 2002-08-06 2010-06-23 ノバルティス アーゲー コンタクトレンズ
EP1629319B1 (de) 2003-05-21 2012-12-12 Novartis AG Kontaktlinsen
GB2426812B (en) * 2005-06-03 2009-11-25 Contact Lens Prec Lab Ltd Improvements in or relating to contact lenses
AR062067A1 (es) 2006-07-17 2008-10-15 Novartis Ag Lentes de contacto toricas con perfil de potencia optica controlado
US7862169B2 (en) 2006-09-29 2011-01-04 Johnson & Johnson Vision Care, Inc. Contact lenses and methods for their design
GB2453993A (en) * 2007-10-25 2009-04-29 Contact Lens Prec Lab Ltd Soft contact lens for correcting abnormal corneal topography
ES2364829B1 (es) * 2010-03-02 2012-12-13 Laboratories Precilens Lente de contacto.

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0503111A1 (de) * 1991-03-13 1992-09-16 Toyohiko Kashiwagi Verfahren und Vorrichtung zur Herstellung einer asphärischen Linse

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5050981A (en) * 1990-07-24 1991-09-24 Johnson & Johnson Vision Products, Inc. Lens design method and resulting aspheric lens
US5684560A (en) * 1995-05-04 1997-11-04 Johnson & Johnson Vision Products, Inc. Concentric ring single vision lens designs
US5650838A (en) * 1995-05-04 1997-07-22 Johnson & Johnson Vision Products, Inc. Programmable smooth junctions on lenses

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0503111A1 (de) * 1991-03-13 1992-09-16 Toyohiko Kashiwagi Verfahren und Vorrichtung zur Herstellung einer asphärischen Linse

Also Published As

Publication number Publication date
JP2002536701A (ja) 2002-10-29
EP1151345A1 (de) 2001-11-07
GB2364138B (en) 2003-09-03
WO2000048036A1 (en) 2000-08-17
GB2364138A (en) 2002-01-16
GB0121521D0 (en) 2001-10-24
DE60027545T2 (de) 2007-04-26
DE60027545D1 (de) 2006-06-01
GB9903170D0 (en) 1999-04-07
ATE324611T1 (de) 2006-05-15
AU2451800A (en) 2000-08-29

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